Home NDC 85350-039 Doloflex Pain Relief
Product NDC 85350-039
11-digit product format 853500039
Labeler code 85350
Product ID 85350-039_40ffa941-e0b5-3f35-e063-6394a90a9d6f
Type HUMAN OTC DRUG
Nonproprietary name Menthol, Methyl Salicylate
Dosage form GEL
Route TOPICAL
Labeler United Health & Beauty Corp
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-17
Substance MENTHOL; METHYL SALICYLATE
Active strength 2; 10 g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Doloflex Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 2 g/100g METHYL SALICYLATE 10 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup LAV5U5022Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2711803 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85350-039-10 Doloflex Pain Relief 300 g in 1 JAR GEL 300 2 85350-039-11 Doloflex Pain Relief 300 g in 1 JAR GEL 300 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85350-039 DOLOFLEX PAIN RELIEF (MENTHOL, METHYL SALICYLATE) GEL [UNITED HEALTH & BEAUTY CORP] 1 Current NDC, 2 package rows 20250416_32a830cc-04d3-102e-e063-6294a90a1cad.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85350-039-10 85350003910 300 g in 1 JAR (85350-039-10) 300 g 2025-03-17 No No Current 85350-039-11 85350003911 300 g in 1 JAR (85350-039-11) 300 g 2025-09-30 No No Current